Recall archive / FDA device enforcement
Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument — FDA record Z-0910-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 10, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument
- Reason
- Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
- Classification
- Class II
- Recalling firm
- Nextremity Solutions
- Quantity
- 4 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0910-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Number: 168117318B, 168125017C UDI: 00817701020011 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution US Nationwide, Japan, and the Netherlands
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 20, 2022
- Recall initiation date
- Feb 10, 2022
- Center classification date
- Apr 12, 2022
- Termination date
- Oct 10, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.